FDA Tells Jepsen It’s On Same E-Cigarette Page

Kendra Baker Photo The U.S. Food and Drug Administration (FDA) shares George Jepsen’s concerns about electronic cigarettes—and plans to step in to regulate them.

The FDA sent that message to Jepsen, Connecticut’s attorney general, and 39 of his colleagues in a letter sent last week.

The attorneys general had asked the FDA to state its position on e-cigarette regulation in a Sept. 24 joint letter. The group wanted to know where the feds stood before exploring whether to seek state regulation of the sale of e-cigarettes to minors. Jepsen and the other attorneys general urged the agency to regulate electronic cigarettes as “tobacco products” under the Tobacco Control Act and prohibit their sale to minors.

E-cigarettes use a battery to heat liquid, turning it into a vapor. The liquid, or “e-juice,” comes in disposable cartridges containing chemicals, vegetable glycerine, flavors and varying amounts of nicotine. The consumer inhales the vapor instead of smoke.

Jepsen said he recognizes the positive benefits of e-cigarettes, such as helping regular cigarette smokers wean off the habit, but said the lack of regulation and multitude of appealing flavors could potentially create “a new generation of nicotine addicts.” According to the Centers for Disease Control and Prevention (CDC), 1.78 million middle and high school students nationwide tried e-cigarettes in 2012.

“The FDA is where the action really is at the federal level. At the state level, we will be introducing legislation that will outlaw sales of e-cigarettes to minors,” said Jepsen, who remained confident that e-cigarette regulation changes would come despite the agency’s failure to meet the deadline. “I wish they would have acted by now [but] the FDA’s going to act eventually.”

In the FDA’s response letter, dated Nov. 14, Deputy Commissioner Sally Howard wrote that like the attorneys general, the FDA is concerned about “the public health impact and lack of existing clinical studies on the potential health risks posed by electronic cigarette use, as well as the manufacture and marketing of these products in ways which could be appealing to minors.”

The attorneys general referenced recent data from the CDC in their letter to the FDA that showed a dramatic rise in e-cigarette use by youth.

The FDA acknowledged the growing popularity of e-cigarettes in its response. The CDC findings “reinforce why FDA intends to extend its authority over products that meet the statutory definition of ‘tobacco products’, when it issues the proposed deeming rule as a first step toward establishing an appropriate regulatory framework to reduce the disease and death from tobacco use,” the letter stated.

The proposed deeming rule, which would expand the its authority to include products that meet the statutory definition of “tobacco product,” is currently under review at the Office of Management and Budget.

Finalization of the rule-making would automatically apply provisions in Chapter IX of the Federal Food, Drug, and Cosmetic Act to all newly deemed products meeting the statutory definition of “tobacco product.”

The FDA currently regulates electronic cigarettes only if they make a therapeutic claim.

“The attorney general appreciates that the FDA shares his concerns, particularly in terms of the sale and marketing of electronic cigarettes to minors,” said Jaclyn Falkowski, director of communications at the attorney general’s office. “While we cannot compel the FDA to take action, he appreciates the FDA’s attention to this matter, in particular that it is seeking the authority to regulate e-cigarettes as a tobacco product.”

Falkowski said if the FDA does not issue regulations, state-level legislation prohibiting the sale of e-cigarettes to minors would be “the appropriate course.”

“Should the FDA issue regulations restricting the sale to minors, such legislation would not be precluded but would not be critical to ensure a prohibition on the sale to minors,” she reported.

About two weeks ago—before the FDA responded to the attorneys general—Connecticut state Sen. Edward Meyer started researching e-cigarettes after discovering that his daughter and grandchild were smoking them.

“I thought this is something that needs more public attention,” said Meyer, who learned that the vaporized nicotine devices lack age regulation. “I called the Connecticut Department of Public Health and asked them what their position is, and I got very upset when they told me they had no position. I urged them to take a position and had a bit of a falling-out with them when they would not.”

Meyer said he intends to push and support legislation that puts public restrictions, including an age limit, on e-cigarettes.

The fast-growing e-cigarette market offers smokers like him flavors ranging from creamy milk chocolate, farm fresh cherry and juicy peach flavors, with a youth market in mind.

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